Sanders et al listed items recommended by FAO/WHO for assessing the safety of probiotics. A qualified presumption of safety (QPS) is used by the European Union to evaluate the safety of a bacterial dietary supplement.


Issues relevant to the safety of a probiotic:

(1) history of safe use

(2) potentially toxic metabolites

(3) toxin production including hemolytic activity

(4) environmental hazards

(5) presence of potentially pathogenic strain(s)

(6) evidence for the transfer of antibiotic resistance factors

(7) recorded side effects in clinical studies

(8) reports from post-market surveillance


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